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Data / Medical devices / Italy / Tecres SPA

Tecres SPA: FDA-registered device maker in VERONA Veneto, Italy, 16 510(k) clearances

Tecres SPA is registered with the FDA (registration 9614841) in VERONA Veneto, Italy. It lists 23 device types. The FDA files 16 510(k) clearances under its listings, the newest dated August 6, 2025. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number
9614841
FEI number
3002808402
Address
Via Andrea Doria 6 Sommacampagna, VERONA Veneto, Italy, 37066
Owner or operator
TECRES SPA (9033624)
Roles
Contract manufacturer, Exporter to the US, Manufacturer
First device listed
June 12, 2001
Registered through
2027
Brand names listed
2Mix, 2Mix Gun, Balloon Inflator, Bone Injection Needles, Bowl and Spatula, CEMENT KIT, Cannula for Knee, Cemex Genta and more

Devices it lists

DeviceProduct codeClassRoleSource
ArthroscopeHRX2Exporter to the US, Manufactureraccessdata.fda.gov
Bone CementLOD2Contract manufacturer, Manufactureraccessdata.fda.gov
Bone Cement, AntibioticMBB2Contract manufacturer, Manufactureraccessdata.fda.gov
Bone Cement, Posterior Screw AugmentationPML2Contract manufactureraccessdata.fda.gov
Cement, Bone, VertebroplastyNDN2Contract manufacturer, Manufactureraccessdata.fda.gov
Dispenser, CementKIH1Exporter to the US, Manufactureraccessdata.fda.gov
Holder, Needle; OrthopedicHXK1Manufactureraccessdata.fda.gov
Injector, Vertebroplasty (Does Not Contain Cement)OAR1Exporter to the US, Manufactureraccessdata.fda.gov
Kit, Surgical Instrument, DisposableKDD1Contract manufacturer, Manufactureraccessdata.fda.gov
Mixer, Cement, For Clinical UseJDZ1Manufactureraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Exporter to the US, Manufactureraccessdata.fda.gov
Orthosis, Spinal Pedicle FixationMNI2Contract manufactureraccessdata.fda.gov
Prosthesis, Elbow, Constrained, CementedJDC2Manufactureraccessdata.fda.gov
Prosthesis, Hip, Cement RestrictorJDK2Manufactureraccessdata.fda.gov
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/PolymerKWZ2Contract manufactureraccessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, MetalKWL2Contract manufacturer, Manufactureraccessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedKWY2Contract manufacturer, Manufactureraccessdata.fda.gov
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerJWH2Contract manufacturer, Manufactureraccessdata.fda.gov
Prosthesis, Shoulder, Hemi-, Humeral, Metallic UncementedHSD2Contract manufacturer, Manufactureraccessdata.fda.gov
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedKWS2Contract manufacturer, Manufactureraccessdata.fda.gov
Spinal Channeling Instrument, VertebroplastyOCJ1Exporter to the US, Manufactureraccessdata.fda.gov
TampHXG1Exporter to the US, Manufactureraccessdata.fda.gov
TemplateHWT1Contract manufacturer, Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
August 6, 2025K252326InterSpace GV Hip SpacerKWLSubstantially EquivalentTecres S.P.A.accessdata.fda.gov
August 16, 2023K223709Kyphoplasty Balloon CatheterHRXSubstantially EquivalentJiangsu Changmei Medtech Co., Ltd.accessdata.fda.gov
April 18, 2022K220131KYPHON VuE Bone CementNDNSubstantially EquivalentTecres S.P.A.accessdata.fda.gov
April 27, 2019K181732InterSpace Knee Extra-Large Size, InterSpace Knee ATSJWHSubstantially EquivalentTecres S.P.A.accessdata.fda.gov
March 5, 2015K143134NP Cement HV;NP Cement LV; NP Cement HV System; NP Cement LV SystemLODSubstantially EquivalentCossington, Ltd.accessdata.fda.gov
March 5, 2015K143100NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP Cement LV System GentaLODSubstantially EquivalentCossington, Ltd.accessdata.fda.gov
March 28, 2013K122175MENDEC SPINE HV, MENDEC SPINE HV SYSTEMNDNSubstantially EquivalentTecres S.P.A.accessdata.fda.gov
December 12, 2011K112983SPACER-SHSDSubstantially EquivalentTecres S.P.A.accessdata.fda.gov
September 20, 2011K101356Spacer-G and Spacer-KKWLSubstantially EquivalentTecres S.P.A.accessdata.fda.gov
November 24, 2009K092773CEMEX GENTA, GENTA SYSTEM AND GENTA SYSTEM FASTLODSubstantially EquivalentTecres S.P.A.accessdata.fda.gov
September 21, 2006K062452KIT MENDEC SPINE AND DELIVERY SYSTEMNDNSubstantially EquivalentTecres S.P.A.accessdata.fda.gov
December 9, 2005K053189COONRAD/MORREY TOTAL ELBOW, MODEL 8105 SERIESJDCSubstantially EquivalentZimmer, Inc.accessdata.fda.gov
June 9, 2005K042415MENDEC SPINENDNSubstantially EquivalentTecres S.P.A.accessdata.fda.gov
August 16, 2002K021765CEMENT RESTRICTOR, SMALL AND LARGEJDKSubstantially EquivalentExactech, Inc.accessdata.fda.gov
June 12, 2002K021715CEMEX RX, CEMEX ISOPLASTIC & CEMEX XLLODSubstantially EquivalentExactech, Inc.accessdata.fda.gov
February 8, 2001K000943CEMEX SYSTEM GUN APPLICATION VERSIONLODSubstantially EquivalentExactech, Inc.accessdata.fda.gov

Compare with other makers

Updated August 6, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.